CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

Computer, Diagnostic, Programmable

BIOSENSE WEBSTER, INC.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System, V1.0 And Accessories.

Pre-market Notification Details

Device IDK090017
510k NumberK090017
Device Name:CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
ClassificationComputer, Diagnostic, Programmable
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactBalaka Das
CorrespondentBalaka Das
BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-02
Decision Date2009-10-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10846835012576 K090017 000
10846835003796 K090017 000
10846835003802 K090017 000
10846835003826 K090017 000
10846835003857 K090017 000
10846835003871 K090017 000
10846835003918 K090017 000
10846835003925 K090017 000
10846835008883 K090017 000
10846835008890 K090017 000
10846835008906 K090017 000
10846835008913 K090017 000
10846835009422 K090017 000
10846835009439 K090017 000
10846835003789 K090017 000

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